Trial Outcomes & Findings for Optimizing Mental Health in Orthopedic Care (NCT NCT05194722)
NCT ID: NCT05194722
Last Updated: 2023-11-09
Results Overview
The PROMIS (Patient-Reported Outcomes Measurement Information System) Depression measure is a brief, computer-adapted measure of depression symptoms. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased depression symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Change in score from baseline to post-treatment (Month 1)
Results posted on
2023-11-09
Participant Flow
Participant milestones
| Measure |
Orthopedic Spine Patients
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Mental Health in Orthopedic Care
Baseline characteristics by cohort
| Measure |
Orthopedic Spine Patients
n=30 Participants
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
21 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in score from baseline to post-treatment (Month 1)The PROMIS (Patient-Reported Outcomes Measurement Information System) Depression measure is a brief, computer-adapted measure of depression symptoms. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased depression symptoms.
Outcome measures
| Measure |
Orthopedic Spine Patients
n=30 Participants
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Adult PROMIS CAT Depression v1.0
|
-1.3 T-score
Interval -2.9 to 0.3
|
PRIMARY outcome
Timeframe: Change in score from baseline to post-treatment (Month 1)The PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety measure is a brief, computer-adapted measure of anxiety symptoms. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased anxiety symptoms.
Outcome measures
| Measure |
Orthopedic Spine Patients
n=30 Participants
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Adult PROMIS CAT Anxiety v1.0
|
-3.2 T-score
Interval -4.3 to -2.0
|
SECONDARY outcome
Timeframe: Change in score from baseline to post-treatment (Month 1)The PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference measure is a brief, computer-adapted measure of how much pain interferes with a person's life. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased pain interference.
Outcome measures
| Measure |
Orthopedic Spine Patients
n=30 Participants
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Adult PROMIS CAT Pain Interference v1.1
|
-3.5 T-score
Interval -4.8 to -2.2
|
SECONDARY outcome
Timeframe: Change in score from baseline to post-treatment (Month 1)The PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function measure is a brief, computer-adapted measure of a person's self-reported physical functioning. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent better physical functioning.
Outcome measures
| Measure |
Orthopedic Spine Patients
n=30 Participants
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Wysa mobile app: Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.
|
|---|---|
|
Adult PROMIS CAT Physical Function v2.0
|
1.4 T-score
Interval -0.2 to 2.9
|
Adverse Events
Orthopedic Spine Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Abby Cheng, MD, PI
Washington University School of Medicine
Phone: 314-747-2823
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place